A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Seps… (NCT07215702) | Clinical Trial Compass
RecruitingPhase 2
A Study to Investigate the Efficacy, Safety, and Tolerability of AZD4144in Participants With Sepsis-associated Acute Kidney Injury.
United States, Argentina, Belgium124 participantsStarted 2026-02-10
Plain-language summary
This study will enroll adults aged 18 to 80 years diagnosed with sepsis due to a suspected or confirmed bacterial infection, within 7 days of being admitted to the hospital, and who have also developed acute kidney injury within 72 hours of the onset of sepsis. Eligible participants will be randomly assigned to receive either AZD4144 or a placebo intravenously once daily for the number of days specified in the CSP. During this Treatment Period, participants will undergo daily safety monitoring, as well as blood and urine sample collection and other assessments. After the Treatment Period, participants will continue to be monitored for safety and other assessments during each additional day they remain hospitalized (if applicable) as well as during up to 2 follow up visits after discharge. The main goal is to compare specific kidney function measurements between those participants receiving AZD4144 and those receiving the placebo.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Age ≥ 18 to ≤ 80 years at the time of signing the informed consent. Participants who are admitted to an ICU or an equivalent critical-care unit.
Diagnosis of sepsis according to criteria defined by The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) based on:
A. Suspected or confirmed bacterial infection AND B. Acute increase of mSOFA score of 2 or more excluding renal component (change in score measured to account for participants that may meet mSOFA criteria from pre-existing organ dysfunction before the onset of infection).
Haemodynamic therapy:
A. 30 mL/kg or clinically appropriate volume resuscitation prior to randomisation.
B. Vasopressor and/or inotrope therapy for sepsis-induced hypotension (eg, norepinephrine \[noradrenaline\], epinephrine \[adrenaline\], phenylephrine, dopamine, dobutamine) for ≥ 4 hours.
Diagnosis of AKI, within 72 hours of sepsis diagnosis, with modified KDIGO Stage ≥ 1, defined as: Increase in SCr to ≥ 1.5 × baseline (outpatient \[preferred\] or admission pre-AKI reference). Timing of AKI diagnosis is defined as the time that the initial qualifying SCr was reported. AKI must persist after completion of initial volume resuscitation (30 mL/kg or as clinically indicated per investigator discretion).
Outpatient pre-AKI reference eGFR ≥ 30 mL/min/1.73 m2, if available within 2 weeks to 12 months prior to admission (preferred). If not available, admission pre-AKI reference eGFR ≥ 45 mL/min/1.73…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1AZD4144 is being tested in a Phase 2 trial, which means it's still in relatively early testing in humans — what do we know so far about its safety profile, and what unknowns should I be aware of before considering whether to discuss enrollment with you?
2The trial is measuring how well the kidneys clear creatinine over 24 hours as its main goal — can you explain what that tells us about kidney function, and whether improvements in that measure would likely translate into meaningful benefits for my recovery from sepsis-associated AKI?
3Since this trial is specifically for people with both sepsis and acute kidney injury at the same time, how would my current condition and the timing of my illness affect whether this study might even be worth discussing as an option for me?
4Are there standard treatments or existing approaches for sepsis-associated AKI that I should consider first, or is this trial something that could potentially be explored alongside or instead of those options?
5Given that I would likely be critically ill during the study period, what does participation actually involve day-to-day — for example, additional monitoring, procedures, or stays in hospital — and how might that affect my care or recovery compared to standard treatment alone?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Curve (AUC) of 24-hour Creatinine Clearance (CrCl).